Ripretinib in Chinese Patients With Advanced GIST: a Real World Study
- Conditions
- Gastrointestinal Stromal Tumors
- Registration Number
- NCT05697107
- Lead Sponsor
- Peking University
- Brief Summary
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world
- Detailed Description
Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 308
-≥18 years old
- Histologically confirmed gastrointestinal stromal tumor (GIST)
- At least one measurable lesion (mRECIST v1.1)
- Received or receiving ripretinib treatment
- Patients who received <1 cycle of ripretinib treatment
- Medical records are incomplete
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS approximately 7 months To assess the efficacy (progression-free survival \[PFS\]
- Secondary Outcome Measures
Name Time Method OS approximately 12 months to assess median overall survival (mOS)
DCR approximately 6 months To assess disease control rate (DCR)
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China